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510(k) Data Aggregation

    K Number
    K230749
    Device Name
    TriMed Threaded Intramedullary Nail System
    Manufacturer
    TriMed, Inc.
    Date Cleared
    2023-04-17

    (31 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K211783
    Predicate For
    K234040
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

    Specific indications for TriMed Small Threaded IM Nails include:

    1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies

    2. Metacarpal fractures, non-unions, malunions and corrective osteotomies

    Device Description

    TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "TriMed Threaded Intramedullary Nail System." This documentation focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or AI device.

    Therefore, many of the requested details about acceptance criteria, test set, ground truth, and human reader performance are not applicable to this type of submission. The device is a bone fixation fastener, not a diagnostic tool or an AI-powered system where such metrics would be relevant.

    However, I can extract information related to the non-clinical performance data that was used to demonstrate substantial equivalence, which can be seen as meeting "acceptance criteria" related to mechanical properties.

    Here's a breakdown of the available information based on your request:

    1. A table of acceptance criteria and the reported device performance

    The submission refers to meeting the recommendations of specific standards and guidance documents, which inherently contain "acceptance criteria" for mechanical performance. The document doesn't explicitly state the numerical acceptance criteria values or the reported device performance values in a direct table format within the provided text. Instead, it states that tests were performed "per the recommendations" and "per ASTM F543-17." This implies that the device met the criteria outlined in those documents.

    Acceptance Criteria (Implied)Reported Device Performance
    Torsional Strength requirements per ASTM F543-17 and FDA GuidanceTested and found to meet requirements per ASTM F543-17 and FDA Guidance
    Driving Torque requirements per ASTM F543-17 and FDA GuidanceTested and found to meet requirements per ASTM F543-17 and FDA Guidance
    Axial Pullout Strength Calculation requirements per ASTM F543-17 and FDA GuidanceTested and found to meet requirements per ASTM F543-17 and FDA Guidance

    2. Sample size used for the test set and the data provenance

    • Sample size for test set: Not explicitly stated. For mechanical tests like these, sample size would typically be determined by the specific ASTM standard (e.g., ASTM F543-17) and internal quality control procedures.
    • Data provenance: Not explicitly stated in terms of country of origin of data. The tests are "non-clinical evidence" conducted on the device itself.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of the device's properties.

    4. Adjudication method for the test set

    • Not Applicable. See point 3.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable. This is a bone fixation fastener, not an AI-assisted diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This is a bone fixation fastener, not an algorithm.

    7. The type of ground truth used

    • Physical Measurements/Engineering Standards: The ground truth for mechanical tests like Torsional Strength, Driving Torque, and Axial Pullout Strength is established by standardized physical measurements according to validated testing methods outlined in documents like ASTM F543-17.

    8. The sample size for the training set

    • Not Applicable. This is a mechanical device, not a machine learning model requiring a training set.

    9. How the ground truth for the training set was established

    • Not Applicable. See point 8.
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